NAVIGATOR HD M0062502230 250-223

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-28 for NAVIGATOR HD M0062502230 250-223 manufactured by Boston Scientific Corporation.

Event Text Entries

[146265173] (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[146265174] It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the device broke inside the patient. The procedure was completed with another navigator hd access sheath. There were no serious injury or adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02742
MDR Report Key8646611
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-28
Date of Report2019-05-28
Date of Event2019-05-07
Date Mfgr Received2019-05-07
Device Manufacturer Date2019-01-06
Date Added to Maude2019-05-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street780 BROOKSIDE DRIVE
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal Code47460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNAVIGATOR HD
Generic NameENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
Product CodeFED
Date Received2019-05-28
Model NumberM0062502230
Catalog Number250-223
Lot Number0023144269
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-28

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